Efficacy and safety of traditional Chinese medicine combined with western medicine for early-phase treatment of acute ischemic stroke based on the primary syndrome elements: protocol for a randomized controlled trial

Background and objective: Acute ischemic stroke is a major cause of disability among adults. Although traditional Chinese medicine and western medicine have been widely used for the treatment of acute ischemic stroke, their efficacy when used in combination for the treatment of acute ischemic stroke during the early phase is poorly understood. According to traditional Chinese medicine theory, the primary syndrome elements of acute ischemic stroke during the early stage include three pathogens, “wind,” “fire,” and “phlegm,” and treatments that target these primary syndrome elements contribute to recovery from the condition. We have designed a randomized controlled trial to investigate the efficacy and safety of traditional Chinese medicine combined with western medicine in the treatment of acute ischemic stroke during the early phase based on the primary syndrome elements.
Subjects and methods: This prospective, single-center, assessor-blinded, randomized controlled trial will enroll 120 eligible patients with acute ischemic stroke who will receive treatment in the Department of Emergency, Dongfang Hospital of Beijing University of Chinese Medicine, China. Participants will be randomly assigned to a combined treatment group or a control group. Both groups will undergo treatment with conventional western medicine, and patients in the combined treatment group will also receive traditional Chinese medicine (i.e., oral stroke initial state decoction, intravenous Gastrodin injection, and Tanreqing injection; Xingnaojing injection will be added for patients who are unconscious). Immediately after admission, patients will undergo 3-day treatment for early-phase ischemic stroke and subsequently undergo a 2-week follow up. This study was approved by Hospital Ethics Committee, Dongfang Hospital, Beijing University of Traditional Medicine, China (approval No. JDF-IRB-2016033602) on November 2, 2016. Written informed consent will be obtained from conscious patients or the legal guardians of unconscious patients.
Outcome measures: The primary outcome measures of this study are the National Institute of Health Stroke Scale score and traditional Chinese medicine stroke scale score on days 1, 3, 7, and 14 after treatment. Secondary outcome measures include National Institute of Health Stroke Scale score, Barthel index, Modified Rankin scale score, Glasgow coma scale score on days 1, 3, 7, and 14 after treatment, serum matrix metalloproteinase-9 and vascular endothelial growth factor levels on days 1 and 3 after treatment. Safety outcomes on days 1 and 3 after treatment and adverse events on days 3, 7, and 14 after treatment are also evaluated.
Discussion: The results of this study will provide evidence to support the rationale for using traditional Chinese medicine combined with western medicine for the treatment of acute ischemic stroke during the early phase, and may indicate the underlying mechanism in this treatment strategy.
Trial registration: This study was registered with the Chinese Clinical Trial Registration (registration number: ChiCTR-INR-16010075) on December 4, 2016. Study protocol refers to 1.0. Patient recruitment began in December 2016 and will be ended in November 2019.